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510(k) K043041

AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) by Aesculap, Inc. — Product Code HCH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2004
Date Received
November 4, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type

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  • K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APP (April 17, 2007)
  • K032198 — AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (August 20, 2003)
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